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See related Tarceva film-coated tab information |
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Manufacturer |
Roche |
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Distributor |
Hong Kong: DKSH/Macau: Firma Chun Cheong |
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Contents |
Erlotinib HCl |
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Indications |
Monotherapy for maintenance of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after 4 cycles of platinum-based 1st-line chemotherapy; monotherapy of locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. In combination w/ gemcitabine, indicated for the 1st-line treatment of patients w/ locally advanced, unresectable or metastatic pancreatic cancer. |
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Dosage |
NSCLC 150 mg once daily. Pancreatic cancer 100 mg once daily. |
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Administration |
Should be taken on an empty stomach (Take on an empty stomach at least 1 hr before or 2 hr after meals.). |
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Special Precautions |
Perform periodic liver function testing. Interstitial lung disease. Severe or persistent diarrhea, nausea, anorexia or vomiting associated w/ dehydration. Hepatic impairment. GI perforation. Reduce exposure in cigarette-smoking patients. Childn <18 yr. Pregnancy & lactation. |
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Adverse Drug Reactions |
Rash, diarrhoea, anorexia, fatigue, dyspnea, cough, nausea, infection, vomiting, stomatitis, pruritus, dry skin, keratoconjunctivitis sicca, abdominal pain, decreased wt, pyrexia, depression, dyspepsia, headache, alopecia, neuropathy, flatulence, rigors, GI bleeding, liver function test abnormalities, keratitis, conjunctivitis, epistaxis.
View ADR Monitoring Form |
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Drug Interactions |
Potent CYP3A4 inhibitors eg ketoconazole, combined CYP3A4/CYP1A2 inhibitors, CYP3A4 inducers eg rifampicin, warfarin or other coumarin-derivative anticoagulants, drugs that alter pH of GI tract, statins.
View more drug interactions with Tarceva |
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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